Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous
tendoachilles lengthening (TAL) after serial casting. This procedure is commonly performed in
the office with a local anesthetic to avoid exposure to general anesthesia in the operating
room. Topical anesthetic creams are commonly used to provide local analgesia for this
procedure. The cream is applied to the infant's skin around the heel cord and requires 30-60
minutes to provide adequate analgesia, reaching a depth of up to 5 mm at maximum effect.
Alternative to analgesic cream, the J-tip is a needle-free jet injection system that uses
compressed CO2 instead of a needle to push 0.25 ml of lidocaine into the skin, providing
local analgesia at the site of administration. This method likewise provides analgesia to the
site of application at a depth of 5-8 mm, yet only takes approximately 1-2 minutes to achieve
maximum effect.
Aim 1: Determine which pain management method, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF
Injection, provides the greatest pain relief to infants with clubfoot undergoing an in-office
percutaneous TAL. Hypothesis: J-tip 1% Xylocaine MPF injection will provide equal or greater
pain control when compared to L.M.X.4 cream in infants undergoing an in-office percutaneous
TAL.
Aim 2: Determine if there is a difference in the rate of adverse events between the two pain
management methods, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection.
Hypothesis: J-tip 1% Xylocaine MPF injection will not be associated with an increased rate of
adverse events in comparison to L.M.X.4 cream in infants undergoing an in-office percutaneous
TAL.
If J-tip Xylocaine MPF injection is shown to provide comparable or better pain control
without an increase in adverse events, use of this needle-free injection system will decrease
the overall length of visit and the cost of the procedure, thus increasing the quality,
safety, and value.